Strengthening Child Social-Emotional and Lifestyle Health in Families Experiencing Stress

May 27, 2026 updated by: Nada Goodrum, University of South Carolina

Strengthening Child Social-Emotional Functioning and Healthy Lifestyle Behaviors Through Parent-Based Prevention in Families Experiencing Major Stressors

This study evaluates feasibility and preliminary efficacy of a parent-based prevention program to promote social-emotional and lifestyle behavior health among 3- to 9-year-old children in families experiencing major stressors.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Social-emotional difficulties and unhealthy lifestyle behaviors are prevalent among children in the U.S. and are associated with negative health outcomes. These challenges are even more pronounced among families who deal with major stressors, such as parental trauma history and mental health difficulties, parental chronic illness (e.g., HIV), parental substance use, economic disadvantage, and racial discrimination. The purpose of this study is to assess the feasibility, acceptability, and preliminary efficacy of a parent-based preventive intervention targeting parental self-regulation, stress reduction, and positive parenting, to promote child social-emotional and lifestyle behavior health, among families where the parents (a) have a child aged 3 to 9 years old, (b) have concerns about their child's behavior, mood, and/or lifestyle health, and (c) are experiencing major stressors. The intervention to be tested is based on Family Life Skills Triple P.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • South Carolina
      • Columbia, South Carolina, United States, 29208
        • University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Child between the ages of 3-9 years

  2. Parent/caregiver willing to engage in the intervention who

    • is at least 18 years of age
    • is primary caregiver or guardian for the participating child
    • has concerns about the child's mood, behavior, and/or lifestyle health
    • is experiencing two or more major stressors of the following: trauma history, mental health difficulties, living with HIV, racial discrimination, substance misuse, and/or financial strain
    • is English speaking.

Exclusion Criteria:

a. Parent or child has

  • a significant cognitive disability, developmental delay, or pervasive developmental disorder
  • active suicidal or homicidal ideation
  • psychotic symptoms (active hallucinations, delusions, or impaired thought processes)
  • ongoing family violence occurring within the home and/or active involvement of child protect services related to child maltreatment allegations.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
Participants in the intervention arm will receive a 12-session parent-based prevention program based on Family Life Skills Triple P.
Behavioral: Family Life Skills Triple P
The intervention is a 12-session program that combines parenting support with trauma-informed life skills coaching. It includes content related to positive parenting strategies, self-regulation, coping with emotions, effective communication, dealing with the past, and developing healthy habits.
No Intervention: Waitlist Control
Participants in the waitlist control arm will not receive any intervention during the clinical trial. They will be placed on a waitlist and then offered the intervention once post assessments are complete.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Intervention acceptability
Time Frame: post-intervention (T2, Weeks 16-18)
Assessed as parent-reported liking and approval of the intervention on a 5-point response scale and satisfaction with the intervention on a 4-point response scale, with higher scores indicating greater acceptability.
post-intervention (T2, Weeks 16-18)
Intervention appropriateness
Time Frame: post-intervention (T2, Weeks 16-18)
Assessed as parent-reported applicability and suitability of the intervention on a 5-point response scale, with higher scores indicating greater appropriateness.
post-intervention (T2, Weeks 16-18)
Intervention feasibility--Implementability
Time Frame: post-intervention (T2, Weeks 16-18)
Assessed as parent-reported ease of use and overall implementability of the intervention on a 5-point response scale, with higher scores indicating greater feasibility.
post-intervention (T2, Weeks 16-18)
Intervention feasibility--Attendance
Time Frame: Weekly throughout intervention period (Weeks 1-17)
Assessed as parent attendance at intervention sessions using weekly attendance logs
Weekly throughout intervention period (Weeks 1-17)
Trial-related feasibility--Recruitment capability
Time Frame: Continuously throughout recruitment period, up to 156 weeks
Assessed as the proportion of eligible children who enroll in the study.
Continuously throughout recruitment period, up to 156 weeks
Trial-related feasibility--Retention
Time Frame: Continuously through study period (Weeks 1-30)
Assessed as the proportion of enrolled children who remain in the study through the length of the intervention, with proportion who dropout and reasons for dropout also collected.
Continuously through study period (Weeks 1-30)
Child social-emotional difficulties: Problem behaviors
Time Frame: baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)
Assessed as parent-reported frequency of child problematic behaviors on a 7-point response scale (higher scores indicate greater frequency).
baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)
Child social-emotional difficulties: Depression and anxiety symptoms
Time Frame: baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)
Assessed as parent-reported frequency of child depression and anxiety symptoms on a 4-point response scale (higher scores indicate greater frequency).
baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)
Child social-emotional difficulties: Strengths and difficulties
Time Frame: baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)
Assessed as parent-reported agreement with statements about child strengths and difficulties on a 3-point response scale (higher scores indicate greater endorsement).
baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)
Child physical activity
Time Frame: baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)
Assessed as daily time spent sedentary and in various activity intensities using a wrist-worn accelerometer.
baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)
Child screen time
Time Frame: baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)
Assessed as parent-reported average daily time spent engaging in screen time, including: watching TV; using a computer; gaming on a console or hand-held device; and using a tablet or smart phone for activities such as viewing videos, playing games, and browsing the internet.
baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)
Child sleep
Time Frame: baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)
Assessed using a wrist-worn accelerometer to calculate nighttime sleep duration and using a validated measure of parent-reported child sleep-wake behaviors on a 6-point response scale, with lower scores indicating more problematic behaviors.
baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Parenting practices
Time Frame: baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)
Assessed as parent self-reported frequency of positive and negative parenting behaviors on a 5-point response scale, with higher subscale scores indicating greater frequency of the respective behaviors.
baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)
Parenting self-regulation
Time Frame: baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)
Assessed as parent self-rated agreement with statements about self-regulation as a parent on a 7-point response scale, with higher scores indicating greater self-regulation.
baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)
Parenting stress
Time Frame: baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)
Assessed as parent self-rated frequency and intensity of daily parenting hassles on a 4--point response scale, with higher scores indicating more frequent and intense hassles.
baseline (T1, Weeks 0-2); post-intervention (T2, Weeks 16-18); follow-up (T3, Week 30)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of South Carolina

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of General Medical Sciences (NIGMS)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nada M Goodrum, Ph.D., University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 9, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 7, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 22, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00123900
  • 5P20GM130420 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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